All being well, the Italian firm will soon have the results from a late-stage study of evenamide in schizophrenia patients who show an inadequate response to atypical antipsychotics.

A key problem with obtaining supplementary protection certificates for combination drug therapies, particularly for “add-on” therapies where patients have access to the remaining active components, was highlighted in a UK court case judgement, the principle of which is expected to be followed in Europe.

Following safety issues raised by the US FDA, no toxicity concerns have emerged in preclinical studies of Newron’s candidate schizophrenia therapy, evenamide, and a clinical safety study has started to evaluate its CNS effects.